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Crosslinked Polymers

Inactive Publication Date: 2011-06-30
USV LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0019]Another object of the invention is to provide a simple, industrially feasible and cost effective process

Problems solved by technology

Thus it is observed that the chloride content of product obtained by the prior art process is not as per the requirement and the process is also not consistent in providing the desired chloride content.

Method used

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  • Crosslinked Polymers
  • Crosslinked Polymers
  • Crosslinked Polymers

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0157]

IngredientsQuantity (g)CoreColesevelam hydrochloride156.250Mannitol20.400Polyvinyl pyrrolidone (Povidone 30)22.500Purified water17.550Isopropyl alcohol62.500Colloidal silicon dioxide2.200Magnesium stearate1.100Film-coatingReady mix film coating material8.800Total228.800

[0158]Procedure: Colesevelam hydrochloride was co-sifted with mannitol (Pearlitol SD 200) using 20# stainless steel sieve and transferred into a rapid mixer granulator and mixed for 5 minutes at 100 rpm. Wet granulation solution was prepared by dissolving povidone in a mixture of isopropyl alcohol and water. Wet granulation solution was added to the Colesevelam-mannitol mixture and mixed at impeller high speed 180 to 200 rpm with chopper off condition for sufficient time till a cohesive mass was formed. The mass was air dried for sufficient time in Glatt drier and further dried at temperature of 50° C. to 60° C. till loss on drying value of about 8% to 12% was achieved. The dried granules were sifted through 100...

example 2

[0159]

IngredientsQuantity (g)CoreColesevelam hydrochloride625.000Mannitol81.600Polyvinyl pyrrolidone (Povidone 30)90.000Purified water70.200Isopropyl alcohol234.800Colloidal silicon dioxide8.800Magnesium stearate4.400Film-coatingReady mix film coating material35.200Total915.200

[0160]Procedure: Colesevelam hydrochloride was co-sifted with mannitol (Pearlitol SD 200) using 20# S. S. Sieve and transferred into Uniglatt fluid bed processor and mixed for 10 minutes. Wet granulation solution was prepared by dissolving povidone in a mixture of isopropyl alcohol and water. The wet granulation solution was sprayed on to the Colesevelam-mannitol mixture in the Uniglatt by top spray mechanism. The mass was dried at temperature of 50° C. to 60° C. for sufficient time till loss on drying value of about 8% to 12% was achieved. The dried granules were sifted through 100# Sieve. Over sized granules were milled using ball mill and the milled mass was sifted through 100# sieve. The sifted granules we...

example 3

[0161]

IngredientsQuantity (g)CoreColesevelam hydrochloride156.250Mannitol25.557Purified water13.980Ethyl cellulose13.813Isopropyl alcohol55.250Colloidal silicon dioxide2.125Magnesium stearate1.063Film-coatingReady mix film coating material8.800Total221.300

[0162]Procedure: Colesevelam hydrochloride was co-sifted with mannitol (Pearlitol SD 200) using 20# S. S. Sieve and transferred into a rapid mixer granulator and mixed for 5 minutes at 100 rpm. Water was added into the rapid mixer granulator and mixed for about 3 minutes at impeller speed of 100 rpm. Wet granulation solution was prepared by dissolving ethyl cellulose in isopropyl alcohol by warming at about 45°-50° C. The binder solution at 45°-50° C. was added to the Colesevelam-mannitol mixture and mixed at impeller high speed 180 to 200 rpm with chopper off condition for sufficient time till a cohesive mass is formed. The mass was air dried for sufficient time in Glatt drier and further dried at temperature of 50 to 60° C. till ...

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Abstract

Disclosed herein are pharmaceutical compositions comprising wet granulated bile acid sequestrants having the general Formula I shown, and their process of preparation. The present invention also discloses process for preparation of Colesevelam hydrochloride, an antilipemic agent.

Description

RELATED APPLICATION[0001]This application is a National Stage entry of PCT / 1N2009 / 000483 filed on Sep. 2, 2009, which in turn claims priority from Indian Provisional Application No. 1860 / MUM / 2008 filed on Sep. 2, 2008.TECHNICAL FIELD[0002]The present invention relates to pharmaceutical compositions comprising wet granulated bile acid sequestrants and their process of preparation. The bile acid sequestrant is a crosslinked polymer selected from the group consisting of Colesevelam, Cholestyramine, Colestipol, Sevelamer and Colestimide. The present invention further relates to the process for preparation of bile acid sequestrants, preferably Colesevelam hydrochloride, an antilipemic agent.BACKGROUND OF THE INVENTION[0003]Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent intended for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. The chemical name (IUPAC) of Colesevelam hydrochloride is allyla...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/785A61K9/14A61K9/20C08G73/02A61P3/00B02C23/18B32B5/00A61K9/28B29C43/02B65B1/20
CPCA61K9/2018A61K9/2027Y10T428/2982A61K31/785A61K9/2866A61P3/00A61K9/16A61K9/20
Inventor SATHE, DHANANJAY GOVINDMONDKAR, HARISH KASHINATHRAO, MANTRIPRAGADA NARAYANPATIL, SAMADHAN DAULATJADHAV, TANAJI SHAMRAOOMRAY, ASHOKCHOUDHARY, VARSHA SHASHANKBHIDE, YOGESH SHARAD
Owner USV LTD
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